On November 12, 2013, the U.S. Marshals, at the request of the U.S. Food and Drug Administration (FDA), seized dietary supplements manufactured and held by Hi-Tech Pharmaceutical, Inc., located in Georgia. According to the FDA, the dietary supplements are adulterated because they contain Dimethylamylamine (DMAA), a new dietary ingredient, in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). DMAA is an amphetamine derivative that is considered unsafe under federal law because it is associated with serious health risks. You can read the FDA’s announcement here.
In October 2013, during an inspection at the Hi-Tech facility, FDA investigators found DMAA ingredients and eleven products containing DMAA or its chemical equivalent. Subsequently, on November 1, 2013, the FDA issued an administrative detention to temporarily hold the products until they were seized. Under section 304(h) of the FDCA, as amended by the Bioterrorism Act of 2002, the FDA is authorized to detain a food or dietary supplement if the agency believes that the product presents a threat of serious health consequences. Under federal law, the FDA is allowed to detain the products for a maximum of thirty (30) days until the agency decides whether to take further enforcement action, such as seizure.
Overall, the FDA’s action against Hi-Tech is part of the agency’s effort to remove DMAA from the market. In April, the FDA sent warning letters to several companies advising them that DMAA-containing products are illegal because DMAA has not been proven safe for consumers. In addition to DMAA issues, this situation highlights the importance of responding adequately to warning letters because failure to do so can subject a company to FDA enforcement actions such as the seizure of products, criminal prosecution, and/or an injunction. More detailed information about responding to warning letters can be found here.
If you have any questions about FDA regulation of dietary supplements, DMAA or FDA warning letters or if you need assistance from a food and drug (FDA) lawyer, please contact us at: firstname.lastname@example.org.